Technical Manager - Peptide Development

Reporting to the Senior Director, CMC Operations, the CMC Technical Manager, Peptide Development is responsible for the technical oversight of peptide programs at CDMO manufacturing sites and in-house R&D activities. This role supports phase-appropriate development, disposition, and distribution of Perspective Therapeutics’ peptide-based radiopharmaceuticals across Phase I-III clinical and pre-commercial programs. The individual will serve as a key technical lead for late-stage peptide development and commercialization activities, including process scale-up, technology transfer, process validation, regulatory submissions, and commercial readiness efforts. This role will ensure compliance with GMP standards, provide oversight of quality-related activities, and serve as a subject matter expert throughout clinical development and commercialization., * Responsible for overseeing all the peptide programs at CDMO and ensuring the activities are completed in a timely manner to support peptide based radiopharmaceutical drug candidates.

• Lead peptide CMC activities supporting process scale-up, technology transfer, process validation, and commercial readiness at internal and external manufacturing sites.
• Responsible for review and approval of master batch records, method validation protocols and reports, test methods, specifications, etc. for early phase clinical, late phase clinical and commercial peptide products.
• Manage the technical and quality aspects of peptide development programs from raw materials through manufacturing, packaging, distribution release and stability, ensuring phase-appropriate GMP compliance and inspection readiness.
• Provide technical leadership for batch record as review, deviation investigations, CAPAs, change controls, product impact assessments, and disposition activities in partnership with Quality Assurance (QA).
• Work closely with QA and early Discovery organizations throughout the development and manufacturing processes.
• Ensure all relevant SOPs are followed to support activities carried out at CDMOs.
• Acting as SME when needed and in providing or reviewing responses to regulatory agency findings from inspections.
• Draft and technical review of IND/IMPD CMC sections, briefing packages, and any other regulatory submissions.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

This is a hybrid position that will require travel to manufacturing sites., * Minimum B.S degree in Chemistry, Biochemistry or related field is required.

• 7+ years’ experience in Pharmaceutical Industry in a similar function.
• Prior experience with peptide synthesis, purification and lyophilization.
• Demonstrated experience leading peptide CMC programs through late-stage clinical development and/or commercialization, including scale-up, technology transfer, process validation, and regulatory interactions with external manufacturing partners.
• Experience supporting quality systems and quality-related activities, including deviations, CAPAs, change controls, investigations, and regulatory inspections.
• Technical writing experience to support CMC module 3.
• Familiarity with Regulatory and Quality Assurance aspects in manufacturing processes of peptide products.
• Technical auditing and Radiopharmaceutical experience are a plus.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Knowledge / Skill / Ability

• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
• Full understanding of GMP and peptide manufacturing, methods validations, specifications, and release/stability.
• Deep understanding of peptide process development, scale-up, manufacturing controls, and commercialization requirements for late-stage clinical and commercial products.
• Strong project management skills, including contracting, budgeting, and timeline oversight.
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Ability to multitask and manage parallel workstreams in a fast-paced drug development environment.
• Ability to travel up to 15%.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Willingness to complete safety training within allotted time limits, and work in a team-based environment.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The annual salary range for this position is $125-160K. For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.